Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients

NCT02990065 | Completed

• 1 other identifier: OPINiB 2016
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purposes of the study are:

• To strictly ensure the appropriate level of protein and caloric provision in critical illness, according to the latest literature recommendation;
• To determine if an association exists between protein intake and nitrogen balance in the context of a nutrition with appropriate protein provision based on the latest literature recommendations, rather than in a standard diet with a caloric target weight-based. Creatinine clearance will also be evaluated to determine if there is any harmful effect to the kidney secondary to an elevated BUN.
• To determine if there is a difference in ICU mortality rate between the current nutrition standard and a hyperproteic nutrition protocol.

Conditions

Protein Deficiency

Keywords

PROTEIN SUPPLEMENTATION; NUTRITIONAL STATUS

Outcome Measures

Primary Outcomes (1)

• nitrogen balance (gr)

  (gr)

  change from baseline through study completion, an average of 15 days

Study Arms (2)

PROTEIN-FORTIFIED DIET

EXPERIMENTAL

The protein-fortified diet consists on an energy goal based on REE measurement and a protein target based on the most recent literature recommendations (1.2-2 g/kg/die) (2). Daily caloric requirement, and subsequent protein content, of patients enrolled in the intervention group will be calculated using formulas in Table 1 (10, 12, 13). For each patient will be calculated the Resting Energy Expenditure (REE) and daily protein requirement (1.2-2g/kg/die of body weight registered at the admission) and the corresponding caloric intake (1g = 4 kcal). Finally, total daily caloric intake will be calculated by adding kcal from protein (1g = 4kcal) on kcal from non-protein (50% of REE).

Dietary Supplement: PROTEIN SUPPLEMENTATION

STANDARD DIET

NO INTERVENTION

The standard diet consists on an energy goal based on weight formula (20-25 kcal/kg/die). According to the ICU nutritional protocol, EN is started at an initial rate of 10ml/h, and increased by 20ml/h every 12 hours in the absence of significant gastric residuals (\<250ml), with the aim of reaching the energy goal within 72 hours from admission. The EN formulae used are standard (1-1,5 kcal/ml, 40g/l protein). If enteral nutrition is not tolerated or is not indicated, supplemental PN is used to make up the energy shortfall. The PN formula used is standard (1000 kcal/l, 37 g/l protein).

Interventions

PROTEIN SUPPLEMENTATION DIETARY_SUPPLEMENT

PROTEIN-FORTIFIED DIET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Receiving PN and/or EN nutrition
• Indwelling urinary catheter
• Mechanically ventilated patients

You may not qualify if:

• Age \< 18 years
• Chronic renal or hepatic failure
• Current or history (past 6 months) of GI bleeding
• BMI \>30 kg/m2 o \<18 kg/m2
• Terminally ill patients
• Pregnancy

Sponsors & Collaborators

• University of Padova: lead

Related Publications (1)

• Danielis M, Lorenzoni G, Cavaliere L, Ruffolo M, Peressoni L, De Monte A, Muzzi R, Beltrame F, Gregori D. Optimizing Protein Intake and Nitrogen Balance (OPINiB) in Adult Critically Ill Patients: A Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 May 9;6(5):e78. doi: 10.2196/resprot.7100.

  PMID: 28487264 DERIVED

MeSH Terms

Conditions

Protein Deficiency

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 12, 2016
• Study Start: January 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: September 30, 2018
• Last Updated: April 28, 2021

Record last verified: 2021-04